Canadian clinical trial registry

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Information is also accessible through the patient and families tab. Family friendly summaries are created and reviewed by our advocacy partners. The information is updated to the best of our knowledge but might not reflect the latest information. Note that most studies are only available at a limited number of sites, please click on ‘further information’ for details. Studies, particularly early phase trials, may also temporarily close to enrolment or not have slots available for all treatment groups. In all cases, study teams at individual C17 centres will have the most up-to-date information.

96 results found

Title
Status

 

AC220-A-U202-ADVL1822 - A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations

Open

AC220-A-U202-ADVL1822 - A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations

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DiagnosisAcute Myeloid Leukemia, AMLStudy StatusOpen
PhaseI/II
AgeChild, Adult - (1 Month to 21 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationQuizartinib by mouth; other drugs are given as usually administered for leukemia therapy.
Last Posted Update2024-03-15
ClinicalTrials.gov #NCT03793478
International Sponsor
Daiichi Sankyo, Inc.
Principal Investigators for Canadian Sites
Montreal Children's Hospital – Dr. Sharon Abish
The Hospital for Sick Children - Dr Ute Bartels
BC Children's Hospital - Dr. Rebecca Deyell
Centres
Medical contact
Clinical Research Unit
 
Social worker/patient navigator contact
Clinical Research Unit
 
Clinical research contact
Stephanie Badour
 
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Rebecca Deyell

 

Social worker/patient navigator contact
Ilana Katz 

 

Clinical research contact
Hem/Onc/BMT Clinical Trials Unit

 

 

 

Study Description

This study is to find the appropriate dose as well as to assess the safety and effectiveness of a drug called quizartinib for children with relapsed or refractory acute myeloid leukemia (AML) with a certain mutation called FLT3-ITD. Quizartinib is a drug designed to specifically block the FLT3 protein when it is abnormal in a leukemia cell.

Inclusion Criteria
  • Children 1 month to 21 years of age
  • Acute myeloid leukemia that has come back or is not responding to current treatment
  • Presence of the FLT3-ITD mutation in the leukemia
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

 

SJMB12 - A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

Closed to enrollment

SJMB12 - A Clinical and Molecular Risk-Directed Therapy for Newly Diagnosed Medulloblastoma

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DiagnosisMedulloblastomaStudy StatusClosed to enrollment
PhaseII
AgeChild, Adult - (3 years to 39 years)RandomisationNO
Line of treatmentFirst line treatment
Routes of Treatment AdministrationVismodegib - Oral. Other drugs are given as usually administered for medulloblastoma therapy
Last Posted Update2024-03-15
ClinicalTrials.gov #NCT01878617
International Sponsor
St. Jude Children's Research Hospital
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Lucie Lafay-Cousin
The Hospital for Sick Children - Dr. Ute Bartels
CHU Ste-Justine- Dr. Sébastien Perreault
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

This study will assess the molecular subtype (abbreviated WNT, SHH, Non-WNT, Non-SHH) of patients with medulloblastoma. Based on the subtype And other factors, patients will be assigned to a "risk group", each risk group receiving specific treatment with chemotherapy and radiation therapy.

Patients with a specific molecular subtype called Sonic Hedgehog (SHH) will be treated with a medication taken by mouth, called vismodegib in addition to standard therapy, to directly target the molecular pathway. 

Inclusion Criteria
  • Patients between 3 and 22 years of age with medulloblastoma.
  • Patients between 22 and 40 years with medulloblastoma of the SHH subtype are eligible.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

GO40871 - A Phase I/II, Multicenter, Open-Label, Multi-Arm Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemias or Solid Tumors

Open

GO40871 - A Phase I/II, Multicenter, Open-Label, Multi-Arm Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination With Either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patients With Relapsed/Refractory Acute Leukemias or Solid Tumors

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DiagnosisAcute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Neuroblastoma, Solid TumorsStudy StatusOpen
PhaseI/II
AgeChild, Adult - (up to 30 Years)RandomisationYES
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationIdasanutlin: oral Note: Other drugs are given as usually administered for acute leukemia & solid tumor therapy
Last Posted Update2024-03-15
ClinicalTrials.gov #NCT04029688
International Sponsor
Hoffmann-La Roche
Principal Investigators for Canadian Sites
Alberta Children's Hospital - Dr. Melanie Finkbeiner
Centres
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich

 

 

Study Description

This study seeks to test the safety and effectiveness of the drug taken by mouth called idasanutlin when taken together with chemotherapy or other cancer drugs (venetoclax) to treat acute leukemias or solid tumors in pediatric or young adults. 

The study is divided into 3 parts. The first part of the study aims to figure out the maximum dose of idasanutlin that can be safely tolerated as well as the recommended dose of idasanutlin when used in combination with chemotherapy and other cancer drugs (venetoclax).

The second part of the study aims to test the safety and effectiveness of idasanutlin in combination with chemotherapy and other cancer drugs (venetoclax) for treating neuroblastoma, acute myeloid leukemia (AML), and acute lymphoblastic leukemia (ALL).

The third part of the study further monitors patients for additional responses to idasanutlin and safety assessments.

Inclusion Criteria
  • Age less than 18 years old or less than 30 years old depending on study groups
  • Diagnosis of neuroblastoma, acute myeloid leukemia (AML), or acute lymphoblastic leukemia (ALL) that has worsened or come back despite the use of standard therapy.
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team

TPX-0005-07 - A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

Open

TPX-0005-07 - A Phase 1/2, Open-Label, Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity Study of Repotrectinib in Pediatric and Young Adult Subjects With Advanced or Metastatic Malignancies Harboring ALK, ROS1, NTRK1-3 Alterations

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DiagnosisNon-Hodgkin Lymphoma, solid tumours, CNS tumours with eligible genetic changesStudy StatusOpen
PhaseI/II
AgeChild, Adult - (Up to 25 Years)RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationRepotrectinib: Oral
Last Posted Update2024-03-15
ClinicalTrials.gov #NCT04094610
International Sponsor
Turning Point Therapeutics, Inc.
Principal Investigators for Canadian Sites
Stollery Children's Hospital - Dr. Sunil Desai
Alberta Children's Hospital - Dr. Victor Lewis
Centres
Medical contact
Dr. Sarah McKillop
Dr. Sunil Desai

 

 

Social worker/patient navigator contact
Danielle Sikora
 Michelle Woytiuk 
Jaime Hobbs
Clinical research contact
Amanda Perreault
Medical contact
Dr. Victor Lewis

 

Social worker/patient navigator contact
Wendy Pelletier
Clinical research contact
Debra Rich

 

 

Study Description

The purpose of this study is to test the safety of a cancer drug called repotrectinib in children. The cancer must have a change in a particular gene (ALK, ROS1 or NTRK). Those gene changes lead to abnormal proteins which may cause cancer cells to grow. Repotrectinib blocks the actions of these genes in cancer cells and can therefore be used to treat cancer.

The first study part (Phase 1) is done to determine what dose level of repotrectinib is safe for children, how the drug is absorbed. This phase is now closed.

The main purpose of the second study part (Phase 2) is to investigate how well and how long different cancer types respond to the treatment with repotrectinib.

 

This study is divided into 2 stages/phases.

The first stage or phase evaluates the safety and tolerability of the drug (repotrectinib) in patients with advanced cancers. This allows researchers to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) which can then be used to select the recommended dose for patients. This phase is now closed.

The second stage or phase will determine the effectiveness of the drug (repotrectinib) in treating advanced cancers.

Inclusion Criteria

For the first phase:

  • Age <12 years
  • Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
  • The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

For the second phase:

  • Age 12 to less than 25 years
  • Patients with advanced or metastatic cancer, including brain tumours or certain types of lymphoma
  • The tumour must have a change in one of the following genes: ALK, ROS1 or NTRK
  • Some patients may be eligible even if they have already received another drug blocking NTRK in the past
  • Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

GO42286 - A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Patients With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available

Open

GO42286 - A Phase I/II, Open-Label, Multicenter, Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Alectinib in Pediatric Patients With ALK Fusion-Positive Solid or CNS Tumors for Whom Prior Treatment Has Proven to be Ineffective or for Whom There is No Satisfactory Treatment Available

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DiagnosisALK Fusion-positive Solid or CNS TumorsStudy StatusOpen
PhaseI/II
Ageup to 17 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationAlectinib: taken by mouth twice daily
Last Posted Update2024-03-15
ClinicalTrials.gov #NCT04774718
International Sponsor
Hoffmann-La Roche
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Vijay Ramaswamy
CHU Ste Justine - Dr. Nicholas Prud'homme
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

Medical contact
Dr. Henrique Bittencourt
Dr. Monia Marzouki
Dr. Sebastien Perreault (neuro-onc)
 
Social worker/patient navigator contact
Marie-Claude Charrette
 
Clinical research contact
Marie Saint-Jacques
 

 

 

Study Description

In this study, researchers are trying to learn more about how safe the study medicine called Alectinib is, and how well they work for children and young people with certain solid or brain cancers where previous treatment has not worked or is not available.

 

Inclusion Criteria
  • Patients must have a confirmed diagnosis of a brain tumour or solid tumor with a specific gene change called "ALK fusion"
  • Patients must have a cancer that has come back (relapsed) or has no standard treatment available
  • Patients must be 17 years old or younger to participate 
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours
  • Patients must have a willingness to complete clinical assessments throughout the study (electronic, paper and/or interviewer methods)

Multiple other inclusion and exclusion criteria could apply and will be reviewed by your treating team.

PBTC-045 - A Safety and Preliminary Efficacy Trial of Pembrolizumab (MK-3475) in Children With Recurrent, Progressive or Refractory Diffuse Intrinsic Pontine Glioma (DIPG), Non-Brainstem High-Grade Gliomas (NB-HGG), Ependymoma, Medulloblastoma or Hypermutated Brain Tumors

Open

PBTC-045 - A Safety and Preliminary Efficacy Trial of Pembrolizumab (MK-3475) in Children With Recurrent, Progressive or Refractory Diffuse Intrinsic Pontine Glioma (DIPG), Non-Brainstem High-Grade Gliomas (NB-HGG), Ependymoma, Medulloblastoma or Hypermutated Brain Tumors

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DiagnosisHigh-Grade Gliomas, Diffuse Intrinsic Pontine Gliomas, Hypermutated Brain Tumors, Ependymoma, MedulloblastomaStudy StatusOpen
PhaseI
Age1 Year to 29 Years RandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Pembrolizumab (IV over 30 minutes)
Last Posted Update2024-02-13
ClinicalTrials.gov #NCT02359565
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Vijay Ramaswamy
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

The purpose of this research study is to investigate an experimental drug, MK-3475 (also called pembrolizumab), in young patients. The drug MK-3475 has been previously studied in adults, in a variety of tumors, but is not yet FDA approved. The first phase is a safety study to assess side effects and best dose of pembrolizumab, the second phase is the efficacy portion to see how well it works in treating childhood brain tumors that have come back (recurrent), progressed, or not responded (refractory) to previous treatment. 

(transcribed from PBTC-045 Summary for Patients and Families)

Inclusion Criteria
  • Patient must have one of the following diagnoses that have come back, progressed or not responded to treatment, to be eligible: 
    • Stratum A : DIPG - currently closed to enrollment
    • Stratum B : Non-brainstem high-grade glioma (NB-HGG)
    • Stratum C : Hypermutated brain tumor
    • Stratum D : Ependymoma
    • Stratum E : Medulloblastoma 
  • Patient must have been treated with prior radiation therapy and/or chemotherapy (exclusions apply)
  • Both males and females of all races and ethnic groups are eligible for this study
  • Patient must be able to be up and about more than 50% of their waking hours
  • Age Requirements:
    • Stratum A  -  1 year to 18 years old during safety portion, <22 years during efficacy, currently closed to enrollment
    • Stratum B  - 1 year to 18 years old during safety portion, <22 years during efficacy
    • Stratum C  - Younger than 30 years old
    • Stratum D  - 1 year to 18 years old during safety portion, <22 years during efficacy
    • Stratum E  - 1 year to 18 years old during safety portion, <22 years during efficacy
  • Patients must have satisfactory blood work prior to enrolling
  • Patient must not have any shortness of breath
  • Human immunodeficiency virus (HIV)-infected patients with undetectable viral load within 6 months are eligible for this trial
  • Patients of child bearing potential must NOT be pregnant, and must agree to use 2 methods of birth control, be surgically sterile, or abstain from heterosexual activity while on study and 6 months after
  • Patient and/or guardian must sign a written consent document

Additional inclusion and exclusion criteria may apply.

PBTC-049 - A Phase I Study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS Tumors Harboring MET Aberrations

Open

PBTC-049 - A Phase I Study of Savolitinib in Recurrent, Progressive or Refractory Medulloblastoma, High-Grade Glioma, Diffuse Intrinsic Pontine Glioma, and CNS Tumors Harboring MET Aberrations

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DiagnosisRecurrent or Refractory Diffuse Intrinsic Pontine Glioma (DIPG), Recurrent or Refractory Malignant Glioma, Recurrent or Refractory Medulloblastoma, Recurrent or Refractory Primary Central Nervous System NeoplasmStudy StatusOpen
PhaseI
Age6 Years to 21 YearsRandomisationN/A
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationDrug: Savolitinib (Oral) Other Names: AZD 6094 AZD6094 HMPL-504 Volitinib
Last Posted Update2024-02-13
ClinicalTrials.gov #NCT03598244
International Sponsor
National Cancer Institute (NCI)
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Vijay Ramaswamy
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

PBTC-049 tests a drug called savolitinib to see how well it works in children with these tumors. This drug has not been studied in children. The hope is that this drug may be a more effective treatment for these types of brain tumors in children.

Therefore, the primary goals of the study are to:

  • Determine which dose of savolitinib is safe for children
  • Learn what effects (good or bad) may occur when patients take savolitinib
  • Learn how the body processes savolitinib

(via: PBTC-049_Summary for patients & families_05-18-2020.pdf)

Inclusion Criteria
  • Patients with confirmed medulloblastoma, high-grade glioma, DIPG brain tumors, and other brain tumor types with a specific genetic marker, which continue to grow or have come back after the prior treatment may be eligible to participate.
  • Patients must be between 5-21 years of age.
  • Patients must have recovered from toxicities of all prior chemotherapy, immunotherapy, radiotherapy or any other treatment modality prior to entering this study.
  • Pregnant women and nursing mothers are excluded from this study
  • Patients or a parent/guardian must understand and sign a written consent form to participate
  • Patients and/or their families must agree to the study visit requirements outlined in the consent form

(via: PBTC-049_Summary for patients & families_05-18-2020.pdf)

Other inclusion criteria may apply and will be discussed with you by the study team.

PBTC-060 - A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma

Open

PBTC-060 - A Pilot Study of SurVaxM in Children Progressive or Relapsed Medulloblastoma, High Grade Glioma, Ependymoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma

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DiagnosisMedulloblastoma, Glioblastoma, Anaplastic Astrocytoma, Oligodendroglioma, Ependymoma, Diffuse Intrinsic Pontine GliomaStudy StatusOpen
PhaseI
Age1 Year to 21 YearsRandomisationNO
Line of treatmentDisease relapse or progression
Routes of Treatment AdministrationBiological: SurVaxM (injection) 500 mcg (1 mL) SurVaxM emulsion with Montanide ISA 51. Sargramostim dose is 3.33 mcg/kg/dose for patients < 30 kg, and 100 mcg for patients ≥ 30 kg.
Last Posted Update2024-02-13
ClinicalTrials.gov #NCT04978727
International Sponsor
Pediatric Brain Tumor Consortium
Principal Investigators for Canadian Sites
The Hospital for Sick Children - Dr. Vijay Ramaswamy
Centres
Medical contact

Dr. Daniel Morgenstern

daniel.morgenstern@sickkids.ca

Social worker/patient navigator contact

Karen Fung 

karen.fung@sickkids.ca

Clinical research contact

New Agent and Innovative Therapies (NAIT) 

nait.info@sickkids.ca

 

 

 

Study Description

Patients on this study will receive 4 doses of a vaccine called SurVaxM. While vaccines are usually thought of as ways to prevent diseases, vaccines can also be used to treat cancer. SurVaxM is designed to tell the body's immune system to look for tumor cells that express a protein called survivin and destroy them. If the body's immune system knows to destroy cells that express survivin, it may help to control tumor growth and recurrence.

 

Inclusion Criteria
  • Participant must have one of the following tumors that has progressed or come back: 
    • Medulloblastoma
    • Glioblastoma multiforme 
    • Anaplastic astrocytoma
    • High-grade astrocytoma, NOS
    • Anaplastic oligodendroglioma
    • Anaplastic ependymoma
    • Ependymoma 
    • Diffuse Intrinsic Pontine Gliomas (DIPG)
  • Participant must be ≥ 1 year of age and ≤ 21 years of age at the time of screening.
  • Participant or parent/guardian must be willing to sign a consent form and complete the study related assessments.
  • Participants must have recovered from all previous cancer therapies. 
  • Must be up and about for around 60% of the patient's waking hours
  • Participants must meet all the blood work requirements 
  • You cannot be pregnant or become pregnant on this study. If you are able to have children, you must use an acceptable form of birth control. Abstinence is included. 

Other inclusion and exclusion criteria may apply and will be discussed with you by the study team.